Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
Lot Numbers/Exp Date: 559344 28th June 2022, 572730 28th July 2023. GTIN: 05055273201130
Products Sold
Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: due to When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results h. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
Recommended Action
Per FDA guidance
Randox USA, Distributor contacted the customer via Urgent Medical Device Correction letter email on 11/1/21. The letter states reason for recall, health risk and action to take: Action to be taken: " Discontinue use of and discard any of the above batches immediately. " Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. If you have any questions or concerns please contact Randox Technical Services.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026